Prospective follow-up of the Prevision hip stem with comparison of implant variants
Official title: Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Run by Aesculap AG · NCT06626490 · Data updated 2026-11-12
This project will test whether adults receiving the Prevision revision hip stem have similar two-year hip function and safety as those who received the previous implant generation or comparable revision stems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 2 sites (Hanover and 1 other locations) |
| Status | Recruiting |
| Started | April 7, 2026 |
| Main results expected | March 2033 |
| Study ends | March 2034 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06626490 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing revision total hip arthroplasty who receive a Prevision revision stem, can give written informed consent, and are able to attend follow‑up visits are eligible.
✕Probably not a fit
Patients under 18, those who are pregnant, held in custody, in a dependent relationship with the sponsor/clinic/investigator, or unable to attend follow‑up visits are not expected to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational post‑market follow-up of patients treated with the Prevision revision hip stem, designed as a non‑inferiority comparison of two‑year functional outcomes measured by the Oxford Hip Score (OHS) against the predecessor implant generation and comparable revision stems. Study sites choose which Prevision variant to implant according to routine practice, with all variants available and switching between variants encouraged. The primary focus is patient‑reported function at two years, with descriptive comparisons of subgroups treated with different stem variants and systematic collection of clinical performance and safety data. No randomized assignment is used; outcomes reflect real‑world use across participating orthopedic centers.
Why it matters
Potential benefit: If successful, the results could confirm that the Prevision family provides comparable two‑year hip function and safety, giving surgeons flexible implant options with consistent patient outcomes.
How similar studies have gone: Modular and variant revision hip stems have been used in clinical practice with generally acceptable outcomes, but this observational follow‑up specifically aims to confirm non‑inferiority for the Prevision family.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Revision hip arthroplasty patients treated with a Prevision hip stem * Written patient informed consent * Patients are able to attend at follow-up examinations Exclusion Criteria: * Patients \< 18 years at surgery * Pregnancy at implantation * Patients held in a custodial setting * Patients in a relationship of dependence on the sponsor, the clinic or the investigator
Where it's running
-
Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7
Hanover, Germany Recruiting -
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, United Kingdom Recruiting
Study contacts
- Principal investigator: Henning Windhagen, Prof. Dr. — Orthopädische Kliniken im Annastift, MHH
- Study coordinator: Kerstin Bergmann
- Email: studies@aesculap.de
- Phone: +49746195-
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.